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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PERIPHERAL ROTAWIRE AND WIRECLIP TORQUER; CATHETER, PERIPHERAL, ATHERECTOMY
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BOSTON SCIENTIFIC CORPORATION PERIPHERAL ROTAWIRE AND WIRECLIP TORQUER; CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Model Number 29711
Device Problems Fracture (1260); Detachment of Device or Device Component (2907); Material Deformation (2976)
Patient Problem Vasoconstriction (2126)
Event Date 02/15/2023
Event Type  Injury  
Event Description
It was reported that the guidewire was fractured and an additional surgery was required.The 100% stenosed target lesion was located in the mildly tortuous and moderately calcified posterior tibial artery (pt).A peripheral rotawire and wireclip torquer - bx5 was selected for use and inserted through a bern catheter.During the procedure, the 5fr bern catheter was removed and left-sided 5/6 fr slender sheath access was lost.Upon reinsertion of the pedal sheath over the wire, the rotawire looped, kinked and broke off in the foot.No hematoma or active bleeding was noted.The physician attempted to re-stick the left pt with the ultrasound guidance, but no vessel was visualized and spasm was presumed.Right common femoral artery access was obtained with a 6fr sheath.However, the physician noticed that the rotawire was now located in the descending superior vena cava.A 6fr snare was used in an attempt to remove the device.The rotawire was pulled into the right common iliac artery, but broke in the snare.The intended procedure was not completed.The patient was then transported to a vascular surgeon for removal of the wire.A small incision was made in the top of the left foot and hemostats were used to remove the rotawire in its entirety.No bleeding occurred and the patient fully recovered after the procedure.
 
Manufacturer Narrative
Correction: h6 device codes: detachment of device or device component.Device evaluated by manufacturer: the device was returned for analysis.Visual & microscopic inspection revealed that the guidewire was observed with a portion detached and not returned, approximately at 10 cm from the distal tip.The device has multiple kinks.Dimensional inspection revealed that the overall length does not meet specifications.The reported complaint was confirmed.
 
Event Description
It was reported that the guidewire was fractured and an additional surgery was required.The 100% stenosed target lesion was located in the mildly tortuous and moderately calcified posterior tibial artery (pt).A peripheral rotawire and wireclip torquer - bx5 was selected for use and inserted through a bern catheter.During the procedure, the 5fr bern catheter was removed and left-sided 5/6 fr slender sheath access was lost.Upon reinsertion of the pedal sheath over the wire, the rotawire looped, kinked and broke off in the foot.No hematoma or active bleeding was noted.The physician attempted to re-stick the left pt with the ultrasound guidance, but no vessel was visualized and spasm was presumed.Right common femoral artery access was obtained with a 6fr sheath.However, the physician noticed that the rotawire was now located in the descending superior vena cava.A 6fr snare was used in an attempt to remove the device.The rotawire was pulled into the right common iliac artery, but broke in the snare.The intended procedure was not completed.The patient was then transported to a vascular surgeon for removal of the wire.A small incision was made in the top of the left foot and hemostats were used to remove the rotawire in its entirety.No bleeding occurred and the patient fully recovered after the procedure.
 
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Brand Name
PERIPHERAL ROTAWIRE AND WIRECLIP TORQUER
Type of Device
CATHETER, PERIPHERAL, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC DE COSTA RICA S.R.L.
302 parkway, global park
la aurora - heredia
CS  
Manufacturer Contact
jeff wallner
4100 hamline ave n
arden hills, MN 55112
6515811560
MDR Report Key16503731
MDR Text Key310889905
Report Number2124215-2023-09086
Device Sequence Number1
Product Code MCW
UDI-Device Identifier08714729838890
UDI-Public08714729838890
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121774
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/19/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number29711
Device Catalogue Number29711
Device Lot Number0030493509
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/06/2023
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/15/2023
Initial Date FDA Received03/08/2023
Supplement Dates Manufacturer Received03/21/2023
Supplement Dates FDA Received04/19/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/07/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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